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NCT Number: NCT05285475

Functional Exercises With Water Intake in Primary Dysmenorrhea

Dysmenorrhea and its associated symptoms are very common in women. In Pakistan, almost 78% of women report Primary Dysmenorrhea. This will be a randomized controlled trial with two parallel groups. one group will be receiving functional exercises along with water intake and the other will be receiving no interventions.

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Key information

Conditions

Primary Dysmenorrhea Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

15 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Behbud Association of Pakistan

Rawalpindi, Fedral, 46000, Pakistan

About this study

Mostly in the reproductive years of age women suffers from the Pain of Menstruation which is known as Dysmenorrhea. In Pakistan every other girl is silently suffers from this disease leading to the inefficiency and one of the main cause of school and work absenteeism. This novel study is designed to target the menstrual symptoms of women with functional exercises combine with optimal intake of water. The objective of this study is to determine the effects of functional exercises with water intake on menstrual symptoms and pain in Primary Dysmenorrhea.

This is a Randomized controlled study. Before the study, all the participants will go through baseline evaluation, and then allocated to the groups. The exercise protocol consisting of the combination of exercises with regular intake of water (in bouts) will be informed to them. Females fulfilling the criteria and willing to participate in exercise trial will be recruited in the study. Outcome will be assessed at baseline and post treatment after 8th week.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age group 15-35
  • Patients with pain at a severity level of 5 on NPRS during menstruation.
  • Primary Dysmenorrhea diagnosis made on WALIDD score
  • Patients having regular menstrual cycle

Exclusion criteria

  • Patients having some previous surgical history
  • Patients diagnosed with Secondary Dysmenorrhea
  • Abnormal Cognition
  • Involved in any regular physical activity for last 6 months

Treatment and study plan

Exercise and Water Intake

Other

The exercise protocol for this group will be abdominals, pelvic stretching and kegels exercises (PFM) for three days/week lasting about 30 minutes with approximately 1600-1800ml (8-10 glasses) intake of water for 8 weeks (two consecutive menstrual cycles)

Exercises include:

Piriformis stretching (5 repetitions×20 seconds) Adductor stretching (5 repetitions×20 seconds) Sit-ups (10 repetitions×3 sets) Bridging (10 repetitions×3 sets) Kegels exercises (10 repetions×3 sets) Pelvic elevation (10 repetitions×3 sets) Pelvic rotation (10 repetitions×3 sets) Cobra pose (5 repetitions×20 seconds)

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: changes from Baseline to 8th week

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: Post 8 weeks

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.

  3. Menstrual Symptom Questionnaire (MSQ)

    Time frame: changes from Baseline to 8th week

    The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items

  4. Menstrual Symptom Questionnaire (MSQ)

    Time frame: post 8th week

    The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: changes from Baseline to 8th week

    The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: post 8th week

    The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Functional Exercises With Water Intake on Sleep Quality and Menstrual Symptoms in Primary Dysmenorrhea

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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